Traditionally, pharmaceutical companies have been reluctant to adopt new technologies
for fear of falling into regulatory non-compliance. The US Food and Drug Administration
(FDA) has defined a framework -- referred to as Process Analytical Technology (PAT)
-- that promotes voluntary implementation of innovative pharmaceutical development,
manufacturing, and quality assurance. Specifically, PAT is a system for designing,
analyzing, and controlling manufacturing through timely measurements (i.e., during
processing) of critical quality and performance attributes of raw and in-process
materials and operations with the goal of ensuring final product quality.
TrakSYS is an effective Process Analytical Technology (PAT) enabler that safely
introduces innovations that drive productivity without risking non-compliance. TrakSYS
takes the guess out of the decision-making process by providing real-time information
to the right people – regardless of where they are. By analyzing the impact of a
multitude of variables across the value chain on product quality, yield, schedule
compliance, goal attainment, and cost, TrakSYS empowers the stakeholders to
make fact-based decisions that can deliver on the promise of quality by design.
That’s why many of the largest global pharmaceutical and medical device companies
have chosen TrakSYS to be an integral part of their operational excellence
and continuous improvement initiatives.